A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability, Immunogenicity, and Pharmacodynamics (PD) of GSK2800528 in Healthy Subjects.

Sponsor
GlaxoSmithKline
Study ID
NCT01899755
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • GSK2800528, solution for injection — DRUG
    Drug will be administered at 3 different dose levels by subcutaneous injection.
  • Placebo (0.9% w/v Sodium Chloride), solution for injection — DRUG
    Subcutaneous injection of. 0.8 mL solution will be administered
  • Adalimumab, solution for injection — DRUG
    Subcutaneous injection of 0.8 mL solution will be administered (40mg)

Study Details

GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12 subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a group of 9 subjects, all on active treatment (adalimumab).

Key Dates

Start date
Jul 10, 2013
Status verified
May 2017
Primary completion
Apr 3, 2014
Completion
Apr 3, 2014

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GSK2800528 Arm
    Subjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo.
  • Placebo Comparator: Placebo Arm
    Subjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo.
  • Active Comparator: Adalimumab Arm
    In Cohort 4, all subjects will receive adalimumab 40 mg (0.8 mL solution) as subcutaneous injection

Primary Outcome Measure

Apparent systemic clearance (CL/F) of GSK2800528 [ Time Frame: Up to Day 196 ]

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